LPS 1987-27-126Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295079453), received between Aug 25, 2017 and Aug 8, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATED DISTAL FEMUR REPLACEMENT AND WAS BROUGHT IN FOR REVISION. A 25 MM IPS SEGMENT AND A 26MM XSMALL LPS HINGE INSERT WERE REMOVED. A NEW 40MM LPS SEGMENT AND 23MM IPS SEGMENT WERE IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 19939128 ↗
• InjuryJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT¿S PREVIOUS PROXIMAL TIBIA REPLACEMENT (2020), CONTINUING TO DISLOCATE POLY OUT OF PROX TIBIA COMPONENT. REVISION SURGERY DEMONSTRATED PROX TIBIA REPLACEMENT COMPONENT WAS ROTATED, CAUSING POLY INSERT TO DISLOCATE FROM POST. ALSO WHEN REMOVED, EVIDENCE OF METAL CHARRING IN THE IMPLANT NOTED, WHICH CAN LEAD TO METALOSIS OF COMPONENTS/TISSUE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> REPLACED PROXIMAL TIBIA COMPONENT, ADDED SEGMENTAL 25MM COMPONENT , WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, OTHER INFORMATION: --> METAL WEAR NOTED , PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> INFLAMMATION, DISLOCATIONS, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IF YES, DESCRIBE --> ROTATION OF COMPONENT IN SEGMENTAL SLEEVE CAUSED REPEATED POLY INSERT DISLOCATIONS AND POTENTIAL METAL BREAKDOWN , IS THE PATIENT PART OF A CLIN

  Patient problems: Inflammation

  MAUDE report 15055063 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE UNKNOWN INTERFACE. FEMORAL COMPONENT AND INSERT WERE REMOVED. WASHED PATIENT OUT AND TRIM PLANTED. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10379087 ↗
• InjuryMar 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SAID THEIR KNEE DISLOCATED WHILE GETTING UP FROM A SITTING POSITION. THE SURGEON WAS ABLE TO PERFORM AN OPEN REDUCTION OF THE KNEE, BUT FOUND THE KNEE WAS STILL A LITTLE TOO LOOSE. HE DECIDED HE WANTED TO UP THE POLY TO A 28MM POLY. THE NEW POLY WAS INSERTED AND A NEW PIN WAS PLACED. KNEE WAS RUN THROUGH A RANGE OF MOTION AND FOUND TO BE SATISFACTORY. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9874203 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INCREASING PAIN, DECREASED RANGE OF MOTION, AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER AND DATE OF IMPLANTATION ARE UNKNOWN. PATELLA WAS WORN AND TIBIAL CONSTRUCT (UNKNOWN PART AND LOT NUMBER) REMAIN INSITU. FEMUR AND PATELLA WERE REVISED. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9451838 ↗
• InjuryNov 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY FELL AND AN I&D WITH AN EXCHANGE OF COMPONENTS WAS PERFORMED ON (B)(6) 2019 THAT WAS CAPTURED UNDER (B)(4). THEN, THE PATIENT WAS REVISED AGAIN DUE TO LOOSENING OF THE FEMORAL SLEEVE AT THE IMPLANT TO BONE INTERFACE AND A DISLOCATION OF THE POLY/TIBIAL INSERT FROM THE TIBIAL TRAY. ALL THE FEMORAL COMPONENTS WERE REVISED AND THE WELL FIXED TIBIAL COMPONENTS WERE RETAINED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9322089 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 7932218 ↗
• InjuryAug 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION RELATED TO PAIN, STIFFNESS, PAINFUL HINGE WITH NICKEL ALLERGY. DOI: (B)(6) 2015; DOR: (B)(6) 2018; (RIGHT, KNEE).

  Patient problems: Hypersensitivity/Allergic reaction; Not Applicable; Pain

  MAUDE report 7776416 ↗
• MalfunctionFeb 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATED THAT OBESE PATIENT WITH HINGE LEFT KNEE- 9 YEARS AGO. IT WAS INDICATED THAT THE PATIENT HAD SHEERED POST OFF THE BOTTOM OF THE POLY AND REVISED TO A 31MM. DOI: 9 YEARS AGO; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267917 ↗
• InjuryAug 25, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LAXITY.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 6821025 ↗